Perspectives On Clinical Studies For Medical Device Submissions

Clinical Outcome Assessments (COAs) in Medical …

https://www.fda.gov/about-fda/cdrh-patient-science-and-engagement-program/clinical-outcome-assessments-coas-medical-device-decision-making

These case studies highlight the roles COAs can play in clinical investigations supporting medical device submissions. They are not intended to be a …

Clinical Trials Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents

Jan 31, 2023

Adaptive Designs for Medical Device Clinical Studies | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-designs-medical-device-clinical-studies

This document addresses adaptive designs for medical device clinical studies and is applicable to premarket medical device submissions including Premarket Approval …

FDA Perspectives on Diagnostic Device Clinical Studies …

https://academic.oup.com/cid/article/52/suppl_4/S305/425319

Patient Engagement in the Design and Conduct of …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-engagement-design-and-conduct-medical-device-clinical-studies

FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. FDA believes medical device clinical studies …

Webinar - Patient Engagement in Medical Device Clinical …

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-patient-engagement-design-and-conduct-medical-device-clinical-studies-final-guidance

The FDA believes including input from patient advisors early in clinical study design may address common challenges, and could result in improved recruitment, retention, and …

Medical Device Clinical Trials: Regulatory …

https://www.greenlight.guru/blog/medical-device-clinical-trials

Clinical trials may be carried out during both the premarket and postmarket phases of the device lifecycle. The graphic below includes the many different types of clinical activities, …

Medical Device Submissions Workshops - AdvaMed

https://www.advamed.org/events/submissions-workshops-spring-2022/

Join us in Spring 2022 for our online Medical Device Submissions Workshops, including: 510 (k), De Novo, IDE and PMA Submissions. This is the ideal …

Clinical Trials for Medical Devices: 5 …

https://www.kolabtree.com/blog/clinical-trials-for-medical-devices-5-expert-tips/

In clinical trials with medical devices, traditional outcomes such as survival, complication rates, or surrogates (biomarkers, imaging techniques, and omics) are used instead of …

FDA Regulatory Submissions: A Primer - Northeastern …

https://www.northeastern.edu/graduate/blog/fda-regulatory-submissions-overview/

The initial IND is a regulatory submission that allows a drug company to proceed to the clinical research phase. These applications can easily exceed 10,000 …